Kornimate/medical-research-clean huggingface dataset:
comparative study of ketamine added to bupivacaine in pecs block versus topical wound instillation on post operative analgesia in modified radical mastectomy surgery

Conditions: Ketamine, Pecs Block, Topical Wound Instillation , Modefied Radical Mastectomy

Summary: comparative study of ketamine added to bupivacaine in pecs block versus topical wound instillation on post operative analgesia in modified radical mastectomy surgery


Eligibility criteria:
inclusion criteria: - 1) female patients aged 18 - 60 years, 2) american society of anesthesiologists (asa) class \| , \|\| , \|\|\| 3) with body weight of 50 - 90 kg . 4) female patients diagnosed with cancer breast and scheduled for modified radical mastectomy . 5) patients not known to be allergic to any of the medications used in the study. exclusion criteria: - 1) patients with known allergy to the study drugs . 2) patients with significant cardiac, respiratory, renal or hepatic disease . 3) patients with drug or alcohol abuse . 4) patients with psychiatric illness that would interfere with perception and assessment of pain. 5) patients with a history of bleeding diathesis; opioid dependence; sepsis; prior surgery in the supraclavicular, infraclavicular or axillary regions.
cardiac output and duplex sonography in carotid endarterectomy

Conditions: Carotid Stenosis

Summary: the aim of this study is to investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (ra) and a general anesthesia (ga) in a randomized, controlled, single center study at the medical university innsbruck, department of anesthesia and intensive care medicine.

the investigators will investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (ra) and a general anesthesia (ga) in a randomized, controlled, single center study at the medical university innsbruck, department of anesthesia and intensive care medicine. for this purpose patients with the need of a carotid endarterectomy (cea) will be included and randomized either to the regional anesthesia (ra) or the general anesthesia (ga) group until a patient number of 45 in each group is achieved. the cardiac output and cerebral blood-flow via trans-cranial doppler (tcd) will be measured at 6 time points: * t0 baseline (after insertion of an arterial line) * t1 after induction of anesthesia, but before surgical start * t2 two minutes after clamping the carotid artery * t3 two minutes after shunt insertation of the carotid artery * t4 after reperfusion * t5 after completion of the skin suture

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. elective carotid endarterectomy 3. signed informed consent exclusion criteria: 1. age under 18 years 2. missing signed informed consent

Keywords: carotid endarterectomy cardiac output trans-cranial doppler cea regional anesthesia general anesthesia
feasibility and safety study of rhbmp-2/cpm for hip fractures

Conditions: Fractures

Summary: the primary objective of this study is to assess the safety of administering rhbmp-2/cpm as an adjuvant to internal fixation in subjects with fractures of the proximal femur.


Eligibility criteria:
inclusion criteria: * age 55 or older. * acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture. * anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail. exclusion criteria: * concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments. * previous arthroplasty of contralateral (unaffected) hip. * planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.

Keywords: fractures
post-marketing study to assess the safety and effectiveness of oral atogepant in korean adult participants for the prevention of chronic or episodic migraine

Conditions: Chronic Migraine; Episodic Migraine; Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. the study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in korean adult patients with chronic migraine or episodic migraine under routine clinical practice. atogepant is an approved drug for preventive treatment of migraine in adults. approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in korea. participants will receive atogepant oral tablets as prescribed by their physician. participants will be followed for up to week 12. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants with migraine suitable for the treatment with atogepant according to the latest approved local label. * participants prescribed atogepant in accordance with the approved local label. exclusion criteria: * participants with any contraindication to atogepant as listed on the latest approved local label. * participants currently participating in another clinical research except observational study.

Keywords: chronic migraine episodic migraine migraine atogepant qulipta aquipta
fixed dose triple therapy in severe chronic obstructive pulmonary disease in a real world setting

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of trimbow® in clinical practice, and to bridge the gap with the existing clinical data.

this non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease. this is an hypothesis generating study. no formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.

Eligibility criteria:
inclusion criteria: * patient has provided written informed consent * patient is aged 40 years or older at time of initiation of trimbow® treatment * patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the global initiative for chronic obstructive lung disease (gold) 2018 classification * patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed trimbow® exclusion criteria: • hypersensitivity to the active substances or to any of the excipients listed below: * ethanol anhydrous * hydrochloric acid * norflurane (propellant)
safety of airway clearance in non-hospitalized infants with acute viral bronchiolitis

Conditions: Bronchiolitis

Summary: bronchiolitis is a disease that can occur in a mild form and moderate, and often does not require hospitalization. the technique of prolonged slow expiration followed by cough caused in children not hospitalized with mild and moderate bronchiolitis can improve clinical severity

once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (id) that is related to its clinical history (ch) by simple coding; custody of the file with the relationship of each id with its ch will be the responsibility of the principal investigator. before starting the treatment protocol, a blind evaluator treats the was assigned the patient classifies the child according to the initial score of clinical severity proposed by wang, in addition to the measurement of so2 and heart rate measured through a pulse oximeter. the protocol consists of 20 minutes of fr based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. the physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum. care must be taken during the maneuvers of maintaining a position of the infant in supine decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting. they are considered as criteria of cessation of the physiotherapeutic intervention, alterations abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion, hiccups or hypertonia and changes in skin color (pallor or cyanosis). in addition to these clinical manifestations, it establishes that if the father or legal guardian demands it, the application of the protocol would be terminated. in order to evaluate the immediate effect of the protocol, which is established as the effect evaluated 10 minutes immediately after the intervention was applied, the doctor again performs a measurement of so2, heart rate and respiratory rate, and classify again according to the criteria of wang's clinical severity scale and anotate any adverse event. at 20 minutes the same medical evaluator performs the same assessment.

Eligibility criteria:
inclusion criteria: patients must meet the following inclusion criteria: * have an age between 2 months and 12 months. * have medical diagnosis of first episode of bq of maximum 48 hours of evolution. * not previously received respiratory physiotherapy since its diagnosis. * have the informed consent signed by the child's legal guardians. exclusion criteria: the exclusion criteria are: * acute bq with score\> 9 according to the wang clinical scale. * pathology associated cardiac, neurological or traumatic. * previous hospitalizations for wheezing. * medical diagnosis of recurrent sibilant.

Keywords: physical therapy respiratory pediatric
nbiaready: online collection of natural history patient-reported outcome measures

Conditions: Neurodegeneration With Brain Iron Accumulation (NBIA)

Summary: the purpose of this study is to learn more about neurodegeneration with brain iron accumulation (nbia) disorders. data is being collected on three types of nbia disorders: pantothenate kinase-associated neurodegeneration (pkan), pla2g6-associated neurodegeneration (plan) and beta-propeller protein-associated neurodegeneration (bpan). the study will (1) collect information about how symptoms and findings in nbia change over time and (2) identify measures of nbia that can be used in future clinical trials. participants will follow links to a secure website every 6 months for a period of 5-10 years to electronically complete a set of rating scales as related to their nbia disorder.


Eligibility criteria:
inclusion criteria: * diagnosis of pkan, plan or bpan confirmed by gene testing and/or clinical features. * ability to access a computer with internet services or a phone approximately once every 6 months for up to 10 years to enter data. exclusion criteria: * individuals who are not fluent in reading and communicating in english.

Keywords: nbia pkan brain iron neurodegeneration with brain iron accumulation hallervorden spatz syndrome pantothenate kinase associated neurodegeneration plan inad pla2g6-associated neurodegeneration bpan beta-propeller protein-associated neurodegenration wdr45 pla2g6
interactive computer-adaptive chronic kidney disease education program

Conditions: Chronic Kidney Diseases; Hypertension

Summary: the goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized african-american patients with advanced chronic kidney disease (ckd). the main question it aims to answer are: does computerized adaptive education (cae) increase patients' knowledge about ckd self-care and renal replacement therapy (rrt) options compared to usual care (uc) and will cae will be increase patients' intent to participate in ckd self-care and rrt preparation compared to uc

the goal of this pilot clinical trial is to evaluate a culturally tailored adaptive computerized education program in hospitalized african-american patients with advanced chronic kidney disease (ckd). the investigator's first hypothesis is that computerized adaptive education (cae) will be more effective than standard of care in improving knowledge about self-care for advanced ckd and renal replacement therapy (rrt) options (primary outcome). the primary outcome is knowledge about ckd and knowledge about rrt. the study team will measure this using the kidney disease knowledge survey (kiks). the investigator's second hypothesis is that cae will increase patients' intent to participate in ckd self-care (to take diabetes and/or hypertension meds, see a nephrologist, and make additional lifestyle changes like smoking cessation, exercise, low-salt diet) compared to standard of care. the study team will measure this using an investigator-developed health intent survey and measure patient activation through the patient activation measure (pam). similarly, the investigator hypothesizes that cae will increase patients' intent to obtain non-catheter access prior to dialysis initiation, to initiate self-care dialysis (peritoneal (pd) or home hemodialysis (hhd), and/or have transplant evaluation compared to standard of care. the study team will measure this using an investigator-developed health intent survey. the investigator's final hypothesis is that cae will increase patients' action at 30 days post-discharge in participating in ckd self-care and ckd health-seeking behavior compared to standard of care controls.

Eligibility criteria:
inclusion criteria: * african-american inpatients * ages 18-70 * estimated glomerular filtration rate (egfr)\<45 * enrolled in the hospitalist project exclusion criteria: * does not self-identify as african american * not able to consent * unable to speak english * egfr \<45 due to acute kidney injury * in intensive care unit * has had a transplant * currently on dialysis

Keywords: african american hospitalized patient education
a study of insulin efsitora alfa (ly3209590) compared to degludec in adults with type 2 diabetes who are starting basal insulin for the first time

Conditions: Diabetes; Type 2 Diabetes

Summary: the purpose of this study is to determine the effect and safety of insulin efsitora alfa (ly3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. the study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. the study will last up to 60 weeks.


Eligibility criteria:
inclusion criteria: * have diagnosis of type 2 diabetes (t2d) according to the world health organization criteria * have an hemoglobin a1c (hba1c) of 7.0 percent (%) - 10.5% inclusive, at screening * are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study * these antihyperglycemic medications are accepted in the study * dipeptidyl peptidase-4 (dpp-4) inhibitors * sodium-glucose cotransporter 2 (sglt2) inhibitors * biguanides, such as metformin * alpha-glucosidase inhibitors * glucagon-like peptide-1 (glp-1) receptor agonists, oral or injectable * sulfonylureas, or * thiazolidinediones. * are insulin naïve. exceptions: * short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes * have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²). exclusion criteria: * have a diagnosis of type 1 diabetes (t1d), latent autoimmune diabetes, or a specific type of diabetes other than t2d, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes. * have a history of greater than (\>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. have had severe hypoglycemia episodes within 6 months prior to screening. have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate. * have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hba1c. * have had new york heart association class iv heart failure or any of these cardiovascular conditions within 3 months prior to screening * acute myocardial infarction * cerebrovascular accident (stroke), or * coronary bypass surgery. * have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example lap-band, or sleeve gastrectomy within 1 year prior to screening * have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.
comparison study of the icon™ cpap series with and without sensawake™

Conditions: Obstructive Sleep Apnea

Summary: conceptually, awareness of pressure occurs only during wakefulness. thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. sensawake™ is a unique pressure relief technology developed by fisher \& paykel healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. when the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep. the purpose of this study is to compare adherence and sleep quality outcomes in patients treated by cpap with and without sensawake technology. it is hypothesised that participants with sensawake on will have improved adherence and sleep quality.


Eligibility criteria:
inclusion criteria: * aged 18-75 years with moderate-to-severe osa (ahi equal to or greater than 10 per hour). * successful in-lab titration polysomnography (psg) * general (at home) sleep habits of: * at least 7 hours in bed on most nights * lights out at 12 midnight or earlier * fluency in both written and spoken english. exclusion criteria: * participants prescribed and fitted with any pap device in the past 2 years * contraindicated for cpap or autocpap therapy. * any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator. * other significant sleep disorder(s) that would interfere with their ability to wear cpap as determined by the principal investigator. * patients who are prescribed hypnotics and sedating medications. * any surgery of the mouth, nose, sinuses or airways (for osa, snoring or otherwise) in the past 12 months. * if participants are required, by the nature of their employment, to comply with therapy. for example truck drivers or airline pilots. * if the physician objects to their patient taking part in the study.
the influence of the greater tuberosity angle on the clinical outcome one year postoperative in patients with a rotator cuff tear

Conditions: Rotator Cuff Tear

Summary: this retrospective study is to investigate the influence of the greater tuberosity angle (gta) in addition to csa on patient outcome in patients with rotator cuff tear.

a tear of the rotator cuff is one of the most common disorders of the shoulder. it is assumed that a large critical shoulder angle (csa) is associated with the occurrence of rotator cuff tears. this retrospective study is to investigate the influence of the greater tuberosity angle (gta) in addition to csa on patient outcome in patients with rotator cuff tear.

Eligibility criteria:
inclusion criteria: * patient after an arthroscopic rotator cuff repair * 1 to 4 years postoperative * presence of pre-operative radiography of the shoulder exclusion criteria: * massive irreparable cuff tear * chronically retracted tendons and atrophic rotator cuff muscles partial arthroscopic repair * absence of pre-operative radiography in neutral rotation

Keywords: critical shoulder angle (csa) greater tuberosity angle (gta)
us-doppler and procoagulant microparticles for the diagnosis of asymptomatic dvt in advanced cancer patients with poor performance status

Conditions: Deep Vein Thrombosis; Cancer

Summary: the aim of this study is to determine the prevalence of asymptomatic lower extremity dvt detected by us-doppler and procoagulant microparticles in a selected group of cancer patients suffering from an advanced stage of the disease. an attempt will be made to determine whether there is a correlation between this prevalence and various clinical and laboratory parameters.

the association between malignancy and venous thromboembolism(vte) is well known. vte is one of the most common complications seen in cancer patients early detection of vte can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality. there are recommendations for hospitalized cancer patients who are bedridden with an acute medical illness to receive prophylaxis, but in practice this is not clear cut.it has been shown, in other selected groups of patients that ultrasound doppler can be used in order to diagnose asymptomatic dvt (deep vein thrombosis). hematological coagulation tests, including procoagulant microparticles will be performed for the evaluation of coagulation profile, in order to evaluate the possible correlation between the prevalence of asymptomatic dvt and these laboratory parameters.

Eligibility criteria:
inclusion criteria: * cancer patients with an advanced stage of the disease, hospitalized in the oncology department. * who performance status of 3( i.e. spends more than half his/her time in bed or seated) - or 4 ( i.e. completely confined to bed or to chair) : for at least a week; according to the treating physician, the poor performance status results from advanced malignancy. * patient is asymptomatic for lower extremity dvt according to the treating physician exclusion criteria: * major surgery during more than a month, from the time of investigation * anticoagulant therapy for more than one month, from the time of investigation

Keywords: deep vein thrombosis cancer us- doppler procoagulant microparticles asymptomatic